| CTRI Number |
CTRI/2009/091/000631 [Registered on: 31/08/2009] |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
This is phase 1 study of comparative evaluation of two formulations of Quetiapine in adult schizophrenic patients. |
Scientific Title of Study
Modification(s)
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An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental comparative evaluation of two formulations of Quetiapine extended release tablets 400 mg under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Quetiapine 400 mg per day. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 054-09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Harshit Shah |
| Designation |
Clinical Team Leader |
| Affiliation |
|
| Address |
Lambda Therapeutic Research Ltd.
Near Gujarat High Court,
S.G. Highway,Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
91-7940202067 |
| Fax |
91-7940202022 |
| Email |
harshitshah@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Nil |
| Address |
Lambda Therapeutic Research Ltd.
Near Gujarat High Court, S.G. Highway,Gota,
Ahmadabad
GUJARAT
380061
India |
| Phone |
91-7940202098 |
| Fax |
91-7940202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Harshit Shah |
| Designation |
Clinical Team Leader |
| Affiliation |
Nil |
| Address |
Lambda Therapeutic Research Ltd.
Near Gujarat High Court, S.G. Highway,Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
91-7940202067 |
| Fax |
91-7940202022 |
| Email |
harshitshah@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas Pharmaceuticals Limited, India.
|
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
2nd floor, Chinnubhai Centre, Ashram Road,Ahmedabad-380 009, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Paliwal |
Anand Hospital & Research Pvt.Ltd. |
Anand Hospital & Research Pvt.Ltd. 7,Sindhu Nagar,Bhanwar Kua Road,Indore-452 001 Madhya Pradesh
Indore
MADHYA PRADESH |
09826044402
0731-2472121
abhaypaliwal@yahoo.com |
| Dr M S Reddy |
Asha Hospital |
Asha Hospital,
298, Road No. 14, Banjara Hills, Hyderabad – 500 034, Andhra Pradesh.
Hyderabad
ANDHRA PRADESH |
09490116098
040-23542574
drmsreddy@gmail.com |
| Dr Ujjwal Sardesai |
Charak Hospital Pvt Ltd. |
Charak Hospital Pvt. Ltd.,
Film Bhavan, Ranisati gate, Y. N. Road,
Indore, Madhya Pradesh
Indore
MADHYA PRADESH |
0731-2548101
0731-2536116
ujwalsardesai@yahoo.co.in |
| Dr Jay Kumbhani |
Manas Psychiatric Hospital & Deaddiction Centre |
Manas Psychiatric Hospital & Deaddiction centre,
301, 3rd floor, Manthan point, Opp. Amisha Hotel,
Una pani road, Surat - 395003, Gujarat.
Surat
GUJARAT |
09328918809
jaykumbhani2001@yahoo.co.in |
| Dr Arun Marwale |
Patne Hospital& Maternity Home |
Patne Hospital& Maternity Home,
Plot.25, Aurangabad Ashoka Premises,
Opp.Taluka Court, Aurangabad-431001, Maharashtra.
Aurangabad
MAHARASHTRA |
09422472725
0240-2356705
a.marwale@rediffmail.com |
| Dr Alexander Gnanadurai |
Psychiatric Clinic, S.K.S Hospital |
Psychiatric Clinic, S.K.S Hospital,
959- TVS Colony, Anna Nagar, West Extn.
Chennai- 600101, Tamil Nadu
Chennai
TAMIL NADU |
09444942665
044-25385868
drdralex@yahoo.com |
| Dr Sanjay Phadke |
Sanjeevani Hospital |
Sanjeevani Hospital,
23 opp. Karve road, Near Garware
College,
Pune-411 004, Maharashtra
Pune
MAHARASHTRA |
09823262786
020-66023400
sanjay_phadke@hotmail.com |
| Dr Bakul Buch |
Santavan, Besides Govt. Hospital |
Santavan,Besides Govt. Hospital,Chitakhana chowk,Junagarh-362 001,Gujarat
Junagadh
GUJARAT |
09825220330
0285-2627311
bakulbuch@gmail.com |
| Dr Vaishal Vora |
Sneh Clinic |
Sneh Clinic, Flat no. 301-2-3,
Nakshatra Complex, Canara bank road,
Above HDFC bank,
Maninagar cross road, Maninagar,
Ahmedabad-380008, Gujarat.
Ahmadabad
GUJARAT |
09825440891
vnvora@gmail.com |
| Umesh Nagapurkar |
Sujata Birla Memorial Hospital and Medical Research Center |
Sujata Birla Memorial Hospital and Medical Research Center, Opp. Bytco college, Nasik Road, Nashik-422101
Nashik
MAHARASHTRA |
0253-2466767
0253-2316189
umeshaman@gmail.com |
| Dr Anil Tambi |
Tambis Clinic |
Tambis Clinic, A-500, Govind Marg,Malavia Nagar,Jaipur- 302017, Rajasthan
Jaipur
RAJASTHAN |
09828899902
0141-2763428
dr.tambianil@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics committee Asha Hospital Banjara Hills Hyderabad Andhra Pradesh |
Approved |
| Independent Ethics Committee, Mehta Hospital, Paldi, Ahmedabad |
Approved |
| Independent Ethics Committee, Mehta Hospital, Paldi, Ahmedabad |
Approved |
| Independent Ethics Committee, Mehta Hospital, Paldi, Ahmedabad |
Approved |
| Independent Ethics Committee, Shradha Nursing Home, Aurangabad |
Approved |
| Independent Ethics Committee, Vidhyadhar Nagar, Jaipur, Rajasthan |
Approved |
| Jnana Prabodhini Medical Trusts_Department of Medical Research_Sanjeevani Hospital, Pune, Maharashtra |
Approved |
| Madras Ethical Committee |
Approved |
| Naitik Independent Ethics Committee, Indore, Madhya Pradesh |
Approved |
| Naitik Independent Ethics Committee, Indore, Madhya Pradesh |
Approved |
| North Maharashtra Ethics Committee, Vakilwadi, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Quetiapine |
Quetiapine 400gm Extended Release Tablets |
| Comparator Agent |
Seroquel XR® |
Quetiapine 400 mg Extended Release Tablets |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Schizophrenic patients, between 18 and 60 years of age (inclusive) and having a Body Mass Index (BMI) between 18 and 30 (inclusive), calculated as weight in kg / height in m2. 2. Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of Quetiapine 400 mg per day for at least 10 days prior to screening 3. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings. 4. The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity or idiosyncratic reaction to quetiapine. 2. Current or relevant history of serious, severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I) except schizophrenia. 3. Presence of Postural Hypotension (Defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing up) 4. History of syncope or orthostatic hypotension 5. Any condition/ Abnormal baseline findings that in the investigator?s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study. 6. Patients with a known intolerance or lack of response to previous treatment with quetiapine. 7. Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period. 8. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others. 9. Patients having Hypertension or on any antihypertensive medication. |
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Cmin,ss, Cmax,ss, AUCÏ„,ss |
NIL |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Ctrough, Tmax, t1/2, PTF, Css,av,λz |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
03/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="2"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Sponsor has developed the test formulation. This study is being conducted to compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor?s formulation (Quetiapine Extended Release tablets 400 mg) with respect to the reference formulation (Seroquel XR 400 mg tablets) in Schizophrenic patients under fasting conditions stabilized on Quetiapine 400 mg per day and to assess the bioequivalence. As a high number of healthy subjects experienced serious adverse effects after administration of antipsychotics such as hypotension, tachycardia etc., regulatory authorities are recommending that studies should be conducted on Schizophrenic patients. Since the formulation being studied is a modified release formulation, a multiple dose, steady state study is being conducted as per the applicable regulatory guidance. The study is being conducted on schizophrenic patients who are on a stable dose of quetiapine, and the patients cannot be deprived of the quetiapine treatment during the washout period of the study. Hence, the study has been planned to be a continuous administration of the test and the reference formulation without any intervening washout period The total number of patients to be enrolled is around 100 from India and the expected date of first enrollment of the patient for the referenced study will be on 02 nd September 2009. |